Compliance and Auditing

When you choose MMS as your partner of choice for Compliance and Auditing Services, adaptable industry experts backed by strong processes will be assigned to your projects.

We are known for our well-defined processes and relentless commitment to delivering the highest quality results on time, consistently.

We assign each Sponsor a dedicated point of contact that manages the delivery of audit tasks to drive timelines, ensuring the consistency of high-quality deliverables and transparency of KPI reporting.

We provide best-in-class reports in a third of the time (33 percent less) than the industry standard: 10 business days for standard audits and 45 calendar days for mock inspection peer-reviewed report delivery.

Our GxP specialists located in the US, Europe, the UK, Latin America, Asia-Pacific, and Africa are available for global assignments.

Investigator Site Audits

• Routine, Targeted and For-Cause
• Inspection Preparation/Training
• Phases I-IV
• Mock Inspections/Pre-Approval
• Inspections

Vendor Audits

• Routine, Targeted, For-Cause
• Qualification/Re-Qualification
• Sponsor Internal, Process, Oversight, and Gap Assessments
• CRO
• Project Management
• Monitoring and Site Management
• Data Management
• Statistical Programming/Biostatistics
• Medical Writing
• Clinical Trial
• Supply/Distributors/Depots
• Interactive Response Technology
• Translation Services
• Archive Facilities
• Medical Monitoring
• Centralized Imaging
• Central, Bioanalytical and/or Specialty labs
• Drug Substance/Biologics
• Manufacturers

Document Audits

• Case Report Forms
• Informed Consent
• Investigator Brochures
• Clinical Study Reports
• Development Safety Update Reports
• Protocol Audits (all Phases)
• Trial Master File Audits (paper/electronic)

System Audits

• Bespoke audits
• Sponsor System/process audits
• Clinical Database audits
• Pharmacovigilance systems

Give your organization the ability to respond confidently to global regulatory authority inspections or investigation requests with inspection readiness and preparations by MMS. Our experts provide comprehensive pre-inspection reviews of facilities, processes, documents, and staff member preparedness including mock inspections.

MMS audit readiness ensures that all Sponsor colleagues are prepared for the variety and volume of requests accompanying any regulatory inspection at their plant or facility, third-party vendors, suppliers, laboratories, clinical sites, and/or contract manufacturers. Additionally, process, document and facility audits are conducted in conjunction, providing the added benefit of uncovering potential observations and allowing for resolution or mitigation before the actual regulatory authority inspection occurs.

Uncovering and addressing findings at this primary juncture provides Sponsors with the added security of knowing that all inspection and compliance potential areas are under control early.

Quality is critical during all phases of pharmaceutical development and becomes a mandatory requirement as the product moves to a marketed product. MMS quality experts are able to navigate your teams for building, auditing, improving, or defending your Quality Management Systems.

Why MMS for Your Quality Needs?



When you choose MMS for your Compliance and Auditing services, you will work with experienced Quality professionals backed by strong processes.

Quality resources are necessary but can be cost prohibitive as full-time overheads. MMS can provide years of experience with multiple areas of expertise in quality and resourcing flexibility.

We assign each sponsor a dedicated point of contact with at least 10 years of experience working within quality.

Your point of contact manages the deliverable to meet timelines, ensuring consistently high quality of deliverables and transparency of KPI reporting.

MMS is known for our well-defined processes with robust internal systems support and our relentless commitment to consistently delivering the highest quality results on time.
We have GxP compliance service staff located in Europe and the US available for global assignments.

Uniquely focused on Quality Assurance, MMS supports a wide range of Sponsors in need of Quality Management Systems (QMS) development, including those completing large-scale mergers and acquisitions that may need to streamline, integrate, and/or improve an existing QMS. MMS experts can provide the support to develop systems & tools for all QA processes.

At MMS, there is no one-size-fits-all approach to providing QMS services – as all organizations have inherent differences. This forward-thinking, risk-based approach ensures that Sponsors gain efficiency and reduce the risk of non-compliance with customized programs for:

• QMS Evaluation and Gap Assessment, by understanding the strengths and weaknesses of your current quality management system.
• Procedure Support, including a thorough evaluation and customized QMS project plan that ensures end-to-end compliance through policies, process maps, standard operating procedures (SOPs), work instructions, and associated forms and templates.
• Organizational Structure Support, including implementing organizational charts, position descriptions, development of strategic business planning framework, and key performance indicators.

Training in a compliance setting can be complex. Sponsors have to demonstrate they have qualified personnel for the position assigned and that they understand the quality responsibilities of their job. Once qualified, Sponsors must repeatedly educate and provide proof of continual proficiency.

A well-thought-out and managed training program is the pillar of a quality program. Training encompasses not just the job to be done but an understanding of the regulations / accreditations and the quality policies established.

MMS can serve as a training partner for all GxP Training needs, as follows:

• Perform a gap assessment of the current training program to evaluate training needs, training requirements, the effectiveness of the training, and the documentation needed
• Create an audit-ready training program that will provide evidence that you meet and exceed quality requirements for qualifying employees and maintaining proficiency
• Develop Training Standard Operating Procedures and training documentation
· Create training modules or courses
· Create GxP training or Inspection Readiness courses to be presented by our staff or yours
• Implement an electronic Learning Management System (LMS) to track all training requirements and completed training in one location

Due to a shift in qualifying contract services through audits, the amount of time spent hosting audits has significantly increased. MMS can provide the resources to manage your hosted audit program.

MMS has experienced employees that have hosted regulatory and accreditation body audits. We will partner with you through our quality programs to build, improve, and defend your quality management systems.

MMS inspectional support can include:

• Assist in preparation for a scheduled or unscheduled audit (inspection readiness)
• Provide comprehensive pre-inspection reviews of facilities, processes, documents, and staff member preparedness
• Train employees on hosting audit
• Create inspection procedures and documentation

FDA 483 observations and warning letters are openly available and can cause concern to the public or be used by competitors as an advantage. Addressing these issues swiftly and sufficiently is extremely important and is best handled by experts in the quality system. MMS is a trusted CRO of choice that can provide resources to:

• Evaluate the finding, investigate root cause, and identify risks
• Prepare a corrective action plan
• A timely draft response to the finding